Announcement of Overseas Expansion Support Plan Centered on the Medical Device Industry Comprehensive Support Center
At a press briefing held on the 19th at the Medical Device Industry Comprehensive Support Center in Jung-gu, Seoul, Hwang Seong-eun, head of the Medical Device and Cosmetics Industry Division at the Promotion Agency (Comprehensive Support Center Director), is making a related presentation. [Photo by Lee Chun-hee]
[Asia Economy Reporter Chunhee Lee] The Korea Health Industry Development Institute (KHIDI) is actively supporting the overseas expansion of K-medical devices in line with global medical device industry trends such as the European Union (EU) Medical Device Regulation (MDR).
At a press conference held on the 19th at the Medical Device Industry Comprehensive Support Center in Jung-gu, Seoul, Hwang Seong-eun, Director of the Medical Device and Cosmetics Industry Division (Head of the Comprehensive Support Center) at KHIDI, stated, "The medical device industry is a representative export-driven industry and a future growth engine," adding, "We hope that KHIDI and the Comprehensive Support Center will serve as a forward base for export support and contribute to bringing South Korea one step closer to becoming a strong export nation in the medical device industry."
KHIDI estimated that the global medical device market size will grow from $454.2 billion (approximately 560 trillion KRW) in 2021 to $663.7 billion (approximately 818 trillion KRW) in 2026, with an average annual growth rate of 7.9%. In particular, the domestic medical device industry has continued explosive growth with an average annual growth rate of 10.2%. The total market size increased from 6.1978 trillion KRW in 2017 to 9.1341 trillion KRW in 2021. Accordingly, KHIDI plans to actively support exports.
The core of export support is handled by the Medical Device Industry Comprehensive Support Center. Since its opening in 2016, it has provided approximately 1,519 consultations to support companies' market entry. A KHIDI official emphasized, "While consultations have so far focused on domestic regulations, from this year we will expand export support and provide focused consultations," adding, "We will practically expand our functions."
The key task is overcoming regulations. Especially, the EU’s medical device approval regulations are critical. In May 2021, the EU changed its medical device approval regulations from the previous Medical Device Directive (MDD) to the Medical Device Regulation (MDR). Accordingly, even companies that had previously obtained certification must re-certify by May 2024; otherwise, their existing certification will become invalid, and the devices cannot be sold within EU member countries.
To address these regulatory challenges, KHIDI plans to activate integrated expert consultations throughout the entire process by expanding the Medical Device Expert Advisory Committee (MDCC) and establish a 'MedTech Export Support Task Force (TF)' within the center to provide focused consultations on overseas exports. The MedTech TF, led by the Ministry of Health and Welfare in cooperation with the Ministry of Trade, Industry and Energy and the Ministry of Food and Drug Safety, supports the entire process from clinical evaluation and testing to certification.
Korea Health Industry Development Institute Medical Device Industry Comprehensive Support Center located in Jung-gu, Seoul Photo by Lee Chunhee
In other areas, support functions that previously only provided simple market information will be transformed into global expansion support through integrated provision of scattered specialized medical device information. Additionally, KHIDI plans to actively support certification acquisition through agreements with related organizations, addressing previously insufficient inter-agency cooperation.
To this end, local bases have been established. Support centers have been set up in Boston, USA; Ho Chi Minh City, Vietnam; and Jakarta, Indonesia, providing consultations on approvals, corporate establishment, participation in local exhibitions, and information services.
KHIDI also explained that it will actively support innovative medical device sectors recently gaining attention, such as artificial intelligence (AI) and digital therapeutics (DTx). Director Hwang said, "We have recently started an integrated review system for innovative medical devices and are discussing regulatory relaxation and insurance reimbursement with the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, and the Health Insurance Review and Assessment Service to enable their practical introduction into medical settings." He added, "Demonstration projects are underway to prove clinical safety and efficacy before export, and for export channels, we plan to conduct international bidding in demand areas through overseas branches or diplomatic missions."
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
